NCT Number: NCT03379532
Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage.
Recent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to re-establish and strengthen CST projections.
Recent studies provided evidence that closed-loop brain computer interface-driven electrical stimulation of the paretic muscles can induce clinically important and lasting recovery of upper limb function, even in patients with chronic, severe motor affection. In this treatment approach, movement intentions of the patients are detected with electroencephalography and real-time analyses. This triggers an electrical stimulation of affected upper limb muscles.
In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface (BCI), can help restore CST projections. This might improve recovery of patients with severe upper limb movement deficits. Treatment will be started within the first 8 weeks after stroke onset.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Division of Neurorehabilitation, University Hospital of Geneva, Geneva, Canton of Geneva, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
From the recorded brain activity (EEG) subject specific patterns will be extracted with machine learning techniques from recordings where the subject executes movements tasks. Whenever a subject-specific pattern can be identified and detected, this is used for triggering neuromuscular electrical stimulation.
Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.
Time frame: Difference between the week before the intervention and the week after intervention
Scale 0-66, higher scores indicate better outcome
Time frame: Difference between the week before the intervention and the week after intervention
Continuous measure, higher amplitude changes indicate better outcome
Time frame: Difference between the week before the intervention and the week after intervention
FA can have values between 0 and 1, higher values indicate better outcome
Time frame: Difference between the week before the intervention and the week after intervention
Computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Scale 0-66, higher scores indicate better outcome
Time frame: Difference between the week before the intervention and the week after intervention
Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Range 18-126, higher values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Range 18-126, higher values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Range 0.04 to 60 g. Lower values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Range 0.04 to 60 g. Lower values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Range 0 to 4. Lower values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Range 0 to 4. Lower values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Scale range 0-57 points, higher values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Scale range 0-57 points, higher values indicate better outcome.
University Hospital, Geneva
Other
Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke
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